KAHR Bio's DSP107 Shows Promising Phase 2 Results in Colorectal Cancer Treatment via Anti-PD-L1 Combination Therapy
KAHR Biotechnology has recently announced promising outcomes from a Phase 2 trial investigating DSP107, a pioneering bi-specific T-cell engager, combined with atezolizumab (Tecentriq®) in patients suffering from third-line microsatellite stable (MSS) metastatic colorectal cancer (CRC). The results were shed light on during an oral presentation led by Dr. Anwaar Saeed at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025, held from May 30 to June 3 in Chicago, Illinois. This combination has shown a noteworthy capacity for eliciting anti-tumor activity and has extended survival, particularly in patients with liver metastases—an area that presents significant treatment challenges.
Colorectal cancer ranks as the second leading cause of cancer fatalities globally and is recognized as a minimally responsive tumor in terms of immune responses. Dr. Saeed emphasized that this innovative combination displays durable results for patients with MSS-CRC, boasting a remarkable median survival advantage compared to existing standard treatments. As an additional benefit, this combination therapy is reported to have meaningful tolerability, presenting far fewer severe side effects commonly associated with chemotherapy regimens typically administered in later-stage cancer scenarios. Importantly, the majority of the patients included in the cohort experienced active liver metastases. The findings underscore the potential of DSP107, together with anti-PD-L1 therapy, as a viable immunotherapy treatment option for this difficult-to-treat patient population, raising hopes for improved outcomes in colorectal cancer treatment.
Yaron Pereg, the CEO of KAHR, stated that they are highly encouraged by data from the dose expansion study, which demonstrates objective responses and prolonged survival rates for patients administered DSP107 in tandem with atezolizumab. Plans are underway to launch a subsequent randomized controlled Phase 2b study to validate the efficacy observations presented. Moreover, KAHR anticipates additional data in 2026 from ongoing examinations of DSP107 in patients experiencing second- or third-line PD-1 treatment for non-small cell lung cancer (NSCLC), a prominent cause of cancer-related deaths.
The recently concluded dose expansion study revealed that both monotherapy with DSP107 and its combination with atezolizumab were well tolerated among participants, showing no dose-limiting toxicities. From the success of the dosage examination involving efficacy, it was noted that the median overall survival (OS) among evaluable patients receiving DSP107 monotherapy (n=19) and combination therapy with atezolizumab (n=21) has yet to be reached but currently stands at 8.1 months for monotherapy and an impressive 17 months for the combined treatment. Disease control was established in 21% of patients receiving the monotherapy, while a notable 62% endured success in the combination cohort, with patients showcasing remarkable responses, including a complete response lasting beyond 2.5 years and another exhibiting a commendable reduction of 86% in targeted lesions along with the disappearance of pulmonary and hepatic metastases.
Investigational efforts regarding DSP107 unveiled the extensive CD47 expression on baseline tumor biopsies, especially in samples collected from liver metastases, where high levels of CD47 were consistently detected. The MSS-CRC dose expansion study was structured as an open-label, multi-center trial (NCT04440735), enrolling third-line MSS patients treated weekly with 10 mg/kg DSP107 and administering atezolizumab (1200 mg) every three weeks until disease progression. The foremost aim was to assess both the safety and tolerability of the combined therapies alongside gauging the preliminary efficacy of DSP107 as an adjunct to atezolizumab.
The abstract associated with this study, titled "Phase 2 dose expansion study of DSP107, a first-in-class bi-specific 4-1BB T-cell engager, with and without atezolizumab in metastatic MSS colorectal cancer patients," has been assigned the publication number 3517. KAHR's lead drug, DSP107, was developed as a first-in-class dual-targeting bi-specific 4-1BB T-cell engager, cleverly exploiting the CD47 overexpression typical in tumor cells. This engagement tricks the immune system into responding to the cancer, marking an innovative step forward in combating colorectal cancer, which presents an intricate treatment challenge due to the typically low presence of immune cells within the tumor.
KAHR continues dedicated efforts to develop groundbreaking fusion protein therapeutics aimed at amplifying immune system responses against cancer effectively. Founded on cutting-edge technology established at the University of Pennsylvania and Thomas Jefferson University, KAHR harnesses the potential of combining innate and adaptive immunity for enhanced patient outcomes.
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